Contemporary Clinical Trials[JOURNAL]
Sun
200 papers
Central data monitoring of clinical trials: A survey of the UK clinical research collaboration (UKCRC) registered clinical trial units.
Hurt C, Casbard A, Kilburn L … +4 more , Lazaroo MJ, Masters L, Haviland J, Love SB
Contemp Clin Trials · 2026 May · PMID 41812889 · Publisher ↗
BACKGROUND: Central data monitoring involves activities performed by trial staff to improve the quality, integrity, and reliability of trial processes and data collection whilst a trial is open. The aim of this research...
BACKGROUND: Central data monitoring involves activities performed by trial staff to improve the quality, integrity, and reliability of trial processes and data collection whilst a trial is open. The aim of this research was to determine the variation in activities conducted and the factors, roles and documentation involved across UKCRC registered clinical trials units (CTUs). METHODS: A survey asking about the central data monitoring activities conducted by trials units was sent to all UKCRC registered CTUs on 25th April 2025. We listed 16 central monitoring activities and asked about whether or not they were conducted on any, some or all trials and which staff role was responsible. RESULTS: Responses were received from 63.5% (33/52) of CTUs) between until 5th June 2025. 8 of the 16 activities: protocol non-compliance, patient flow (e.g., CONSORT chart), recruitment versus predicted recruitment, eligibility issues, consent issues, data completeness for primary analysis, missing case report forms (CRFs), and data outliers, are conducted for all trials by at least 27/33 (81.8%) of the units and for some trials by all the trials units. 10/16 (62.5%) of the activities were done by a mixture of staff roles at the majority of units. CONCLUSIONS: Our survey shows the variety in the central data monitoring activities conducted by UKCRC CTUs and the variation as to who is conducting these activities. We recommend actions to improve the consistency and quality of monitoring in trials run by UKCRC-registered CTUs. When setting up new trials, CTUs should consider implementing the central data monitoring activities described, with particular emphasis on the eight activities undertaken by all units surveyed.
Study protocol for weSurvive: A feasibility trial of a digital health intervention to improve quality of life and health behaviors of Appalachian cancer survivors.
Porter KJ, You W, Foreman BR … +4 more , LeBaron VT, Brock DP, Jones CJ, Zoellner JM
Contemp Clin Trials · 2026 May · PMID 41802648 · Publisher ↗
More individuals diagnosed with cancer are living longer; yet many post-treatment cancer survivors engage in unhealthful energy-balance related behaviors (EBRBs, i.e., nutrition and physical activity behaviors) that incr...
More individuals diagnosed with cancer are living longer; yet many post-treatment cancer survivors engage in unhealthful energy-balance related behaviors (EBRBs, i.e., nutrition and physical activity behaviors) that increase risk for cancer recurrence and other chronic diseases and decrease their quality of life (QoL). Behavioral interventions can improve the EBRBs of cancer survivors, yet none have been designed to meet the needs of cancer survivors in Appalachia, a largely rural and medically underserved region that experiences cancer disparities. This trial targets this gap by evaluating the feasibility of weSurvive, a novel digital health intervention designed to improve QoL for post-treatment cancer survivors living in or near Appalachia by targeting EBRBs. weSurvive is ground in Social Cognitive Theory and consists of three components: eight group sessions, three coaching calls, and weekly text messages. Using a randomized control trial with a robust process evaluation informed by Bowen's feasibility framework, this trial seeks to determine the feasibility of the weSurvive intervention among post-treatment cancer survivors (n = 114). The trial aims are to assess (1) changes in QoL (primary outcome) and other limited efficacy outcomes (e.g., changes in EBRBs) in intervention participants compared to those in delayed contact at 6-months, (2) maintenance of limited efficacy outcomes among intervention participants, and (3) other feasibility indicators at the participant- and system-levels (i.e., acceptability, practicality, demand, integration). The long-term goal is to develop and implement an effective and scalable behavioral intervention to improve the QoL of post-treatment cancer survivors in Appalachian communities and other rural populations.
Non-inferiority, comparative effectiveness study of intravenous ketamine v. intranasal esketamine for treatment-resistant depression: The EQUIVALENCE trial protocol.
Wilkinson ST, Prashad S, Dalthorp R … +10 more , Harding L, Kitay B, Parikh SV, Dziura J, Clayton A, Fram G, Lepoutre V, Brown J, Ostroff RB, Sanacora G
Contemp Clin Trials · 2026 May · PMID 41780747 · Publisher ↗
Ketamine is a powerful and rapid-acting antidepressant but has no regulatory authorization for any psychiatric illness. The S-enantiomer of ketamine, esketamine, was approved by the FDA in 2019 as adjunctive therapy for...
Ketamine is a powerful and rapid-acting antidepressant but has no regulatory authorization for any psychiatric illness. The S-enantiomer of ketamine, esketamine, was approved by the FDA in 2019 as adjunctive therapy for treatment-resistant depression. Substantial controversy exists as to whether there is a significant clinical difference between intravenous (IV) ketamine racemate and intranasal esketamine. The EQUIVALENCE protocol will directly compare these therapies for treatment-resistant depression (TRD). Patients with TRD are randomized (1:1) to receive 8 treatments of IV ketamine or IN esketamine over a 4-week period. The primary outcome is change in depression severity as measured by a patient-reported outcome, the Quick Inventory of Depressive Symptomatology (QIDS) after 4 weeks of treatment. The study is designed as a non-inferiority study, with the FDA-approved therapy, esketamine, considered the standard. With a sample size of 400 total (200 per group), the study is powered to declare non-inferiority within a margin of 1.6 on the QIDS. If IV ketamine is found to be non-inferior to esketamine, a subsequent statistical test will examine whether ketamine is superior. Secondary outcomes include response and remission rates, anxiety severity, quality of life, and patient satisfaction, acceptability, and tolerability. We will also examine whether TRD with anxious distress responds differentially to one treatment or the other and the role that patient preference plays in outcomes. Results of the EQUIVALENCE study will have important implications for patient choice, health insurance coverage policies, and clinical care for TRD.
Protocol paper for an implementation science approach to promoting colorectal cancer screening in Federally Qualified Health Center Clinics: A stepped-wedge, multilevel intervention trial.
Montoya SM, Olaore P, Bastardo-Acosta J … +12 more , Abdulla R, Schell MJ, Hidalgo A, Turner B, Rider M, Kishun-Jit N, Pollard J, Friedman M, Byrne MM, Christy SM, Meade CD, Gwede CK
Contemp Clin Trials · 2026 May · PMID 41780746 · Full text
BACKGROUND: Colorectal cancer (CRC) is the third leading cause of cancer-related deaths in the United States. Despite national goals to increase CRC screening, rates in Federally Qualified Health Centers (FQHCs) are subo...
BACKGROUND: Colorectal cancer (CRC) is the third leading cause of cancer-related deaths in the United States. Despite national goals to increase CRC screening, rates in Federally Qualified Health Centers (FQHCs) are suboptimal at about 40%. This paper describes the design and implementation plan for the Colorectal Cancer Awareness, Research, Education and Screening-Rural Expansion, Access, and Capacity for Health (CARES-REACH) study that accelerates the adoption of evidence-based screening practices. METHODS: Informed by a community-based participatory research framework and implementation science approaches, CARES-REACH features a stepped wedge design with extension for maintenance to support an implementation strategy focused on organizational, provider, and patient levels to boost initial and repeat screening among average-risk, age-eligible adults. This study implements a core set of evidence-based interventions (EBIs), including low-literacy patient education, provider education, system-wide electronic medical record tools (provider prompts and patient reminders), fecal immunochemical test kit distribution, plus an organization-wide cancer control champion who motivates providers, coaches patients, and monitors system-wide screening activities. Study aims to: 1) implement an organization-wide multilevel CRC intervention using EBIs plus a cancer control champion in FQHCs in rural and urban Florida; 2) explore whether practice setting and population characteristics may differentially impact annual CRC Uniform Data System (UDS) rates; and 3) conduct a comprehensive evaluation of the implementation and resource requirements for FQHCs. Our hypothesis is that the UDS rates will increase by ten percentage points per year. DISCUSSION: Findings will inform multilevel strategies to enhance cancer screening in health systems, inform scale-up, and benefit patients and communities. CLINICAL TRIALS REGISTRATION: NCT04464668 (Date Registered: 2020-07-09).
Randomized clinical trial protocol: Acceptability and feasibility of combination treatment for cervical precancer among South African women living with HIV (ACT 2).
Chibwesha CJ, Mollan KR, Teodoro NS … +7 more , Keys JR, Liu C, Mulongo M, Gumede S, Pasipamire T, Faesen M, Rahangdale L
Contemp Clin Trials · 2026 May · PMID 41780745 · Full text
BACKGROUND: Global efforts to eliminate cervical cancer currently focus on expanding access to human papillomavirus (HPV) vaccination and cervical screening. However, these efforts lack equal investment in the treatment...
BACKGROUND: Global efforts to eliminate cervical cancer currently focus on expanding access to human papillomavirus (HPV) vaccination and cervical screening. However, these efforts lack equal investment in the treatment of precancerous cervical intraepithelial neoplasia grade 2/3 (CIN2/3), particularly among women living with human immunodeficiency virus (HIV; WLWH). This gap leaves a generation of WLWH at high risk of persistent/recurrent CIN2/3 and progression to cervical cancer, as standard surgical treatments are less effective in this population. METHODS AND DESIGN: We conducted a randomized, placebo-controlled trial to evaluate the acceptability and feasibility of combination treatment for CIN2/3 among WLWH in South Africa. As part of the trial, 180 WLWH with CIN2/3 were randomly allocated (1:1) to undergo loop electrosurgical excision procedure (LEEP) followed by self-administration of 8 doses of intravaginal 5% 5-fluorouracil (5FU) or placebo cream (one dose every other week for 16 weeks). Women were followed for 24 weeks. The primary outcomes were acceptability and feasibility (safety, tolerability, adherence, retention). Secondary outcomes included (a) regression of cervical disease to cervical intraepithelial neoplasia grade 1 (CIN1) or normal histology and (b) clearance of the high-risk HPV (hrHPV) genotype(s) detected at baseline. DISCUSSION: This feasibility trial was conducted in preparation for a large-scale effectiveness trial of LEEP combined with intravaginal 5FU for CIN2/3 among WLWH. If proven acceptable, feasible, and effective, topical 5FU may be repurposed as a low-cost, self-administered adjuvant treatment to reduce persistent/recurrent CIN2/3 and progression to cervical cancer in this high-risk population. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05413811.
Protocol for a randomized trial of a scalable, interactive tool to support surrogate decision-makers of critically ill patients.
Olszewski AE, Butler RA, Ashana DC … +12 more , Carson S, Cox CE, Hough CL, Hwang DY, Maloney D, Mayr F, Menon V, Steingrub JS, Sullivan DR, Vincent G, Wendlandt B, White D
Contemp Clin Trials · 2026 May · PMID 41730449 · Publisher ↗
BACKGROUND: Patients, particularly those at the end of their lives, frequently receive goal-discordant care, and their surrogate decision-makers suffer long-term psychological injury. Contributors to these issues may inc...
BACKGROUND: Patients, particularly those at the end of their lives, frequently receive goal-discordant care, and their surrogate decision-makers suffer long-term psychological injury. Contributors to these issues may include infrequent communication between clinicians and surrogates, failure to discuss prognosis, values, and treatment options that include comfort-focused care, and surrogates facing high-stakes decision-making while underprepared and overwhelmed psychologically and emotionally. DESIGN: This is a multicenter, patient-randomized efficacy trial of a multi-component intervention, versus usual care, for 370 incapacitated, critically ill adults at high risk of death or severe disability, and their surrogate decision-makers, from 7 hospitals across the United States. INTERVENTION: The intervention combines surrogate utilization of a digital Family Support Tool (FST) in real-time during their loved one's hospitalization with proactively scheduled family meetings, for which both surrogates and clinicians receive additional preparation, at set intervals during the ICU hospitalization. Those in the control arm will receive usual ICU care. OUTCOMES: Our primary outcome is patient-centeredness of care, measured using the modified Patient Perceived Patient-Centeredness of Care (PPPC) scale. Secondary outcomes include surrogates' psychological symptom burden, communication and decision quality, and patients' health resource utilization and clinical outcomes. CONCLUSION: This trial will provide robust evidence about the impact of combining the FST with increased and intentional communication, on patient, family, and health system outcomes for those hospitalized in the ICU.
A pilot trial of 'HypoPals': Assessing trial procedures feasibility and intervention acceptability for a prospective digital hypoglycemia behavioral intervention study.
Lin YK, Hepworth E, Lucien J … +12 more , Agni A, Martin-Schwarze A, Newman S, Marinec N, Aikens JE, Spino C, Pop-Busui R, Strayhorn J, DeJonckheere M, de Zoysa N, Amiel SA, Piette JD
Contemp Clin Trials · 2026 Apr · PMID 41724265 · Full text
BACKGROUND: Despite advances in diabetes technology, hypoglycemia remains a major problem for people with type 1 diabetes (T1D). We developed HypoPals, a scalable digital behavioral intervention program comprised of two...
BACKGROUND: Despite advances in diabetes technology, hypoglycemia remains a major problem for people with type 1 diabetes (T1D). We developed HypoPals, a scalable digital behavioral intervention program comprised of two intervention components, (i) hypoglycemia symptom detection training ('SDT') and (ii) psychoeducation to address unhelpful hypoglycemia beliefs (Education Plus, 'ED+'), to improve hypoglycemia self-management in adults with T1D. METHODS: A 52-week pilot study was conducted to assess the feasibility of a prospective decentralized 2 × 2 factorial trial with the following characteristics: participant recruitment from a national T1D patient registry; minimization randomization; and remote outcome data collection to evaluate the effectiveness of HypoPals intervention components. This pilot study's primary outcome was the number of participants needed to achieve 20 participants completing the intervention. Intervention acceptability was also assessed. RESULTS: Forty participants were randomized to receive 10 weeks of either SDT only; ED+ only; both; or usual care only. All participants completed the intervention. Thus, 20 participants were recruited to achieve 20 participants completing the intervention. No significant differences in baseline characteristics were observed across randomization groups. Retention was 98% at the 26- and 52-week follow-ups, and 98% of participants provided complete outcome data. The majority (88%) found HypoPals at least somewhat helpful. No adverse events were determined to be related to the intervention. CONCLUSIONS: This pilot trial demonstrated the feasibility of both integrating multiple advanced trial strategies and the intervention's acceptability. Results supported the conduct of a large-scale, decentralized, factorial trial to evaluate HypoPals' effectiveness in reducing hypoglycemia in adults with T1D.
Combined adapted physical activity and art-therapy intervention in myasthenia gravis: Study protocol for a randomized crossover pilot trial.
Leclercq C, Archer A, Ceccone F … +4 more , Davion JB, Devanne H, Tard C, Porrovecchio A
Contemp Clin Trials · 2026 Apr · PMID 41720335 · Publisher ↗
BACKGROUND: Myasthenia Gravis (MG) is a rare autoimmune disorder with fluctuating weakness and substantial impact on quality of life (QoL). Despite advances in pharmacological treatment, patients often experience fatigue...
BACKGROUND: Myasthenia Gravis (MG) is a rare autoimmune disorder with fluctuating weakness and substantial impact on quality of life (QoL). Despite advances in pharmacological treatment, patients often experience fatigue, anxiety, and reduced daily functioning. Adapted Physical Activity (APA) has shown benefits in chronic neuromuscular disorders, while Art Therapy (AT) has demonstrated positive psychosocial effects in neurological conditions. However, no studies have investigated the potential synergy of APA combined with AT in MG. METHODS: We designed a monocentric, prospective, randomized crossover pilot trial to evaluate the feasibility and preliminary efficacy of an integrated APA + AT program compared to APA alone. A total of 102 adult patients with MG will be recruited from Lille University Hospital and partner centers. Each participant will undergo two 6-week phases (APA only vs APA + AT), separated by a 46-week washout. Primary outcome is change in QoL (MG-QOL15) at 3 months. Secondary outcomes include fatigue (FSS), anxiety and depression (HADS), activities of daily living (MG-ADL), physical function tests, physical activity (IPAQ, accelerometry), and psychosocial outcomes assessed through qualitative methods (interviews, ethnography, creative elicitation). Quantitative data will be analyzed with repeated-measures models; qualitative data will undergo thematic analysis. DISCUSSION: This trial will be the first to explore a combined APA + AT intervention in MG. By addressing both physical and psychosocial dimensions, the study may provide evidence for integrated, patient-centered care strategies in rare neuromuscular disorders. If feasible and effective, results could inform future multicenter trials and clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT07125105.
Effectiveness and implementation of an embedded community-based heart-age risk education model (E-CHARM) in improving cardiovascular risk awareness and health behaviors among older adults with hypertension: Protocol for a randomized controlled trial.
Wang G, Huang Y, Li B … +8 more , Zuo Y, Song W, Li Y, Sun Y, Xue N, Wang Z, Wang T, Hu Z
Contemp Clin Trials · 2026 Apr · PMID 41713746 · Publisher ↗
BACKGROUND: Cardiovascular disease (CVD) is the leading cause of mortality in China, with hypertension as the most common modifiable risk factor. Despite comprehensive primary care based on chronic disease management, pa...
BACKGROUND: Cardiovascular disease (CVD) is the leading cause of mortality in China, with hypertension as the most common modifiable risk factor. Despite comprehensive primary care based on chronic disease management, patients' awareness of CVD risk and motivation for self-management remain suboptimal. METHODS: This study is a parallel-group, individually randomized controlled trial conducted within routine chronic disease management at a community health center in Kunshan, China. Approximately 400 adults aged 60 years and above with hypertension will be randomly allocated (1:1) to receive either a personalized Heart Age report with brief physician explanation or usual care. The primary outcome is CVD risk awareness at 3 months. Secondary outcomes include changes in self-reported physical activity, diet, and medication adherence. An exploratory analysis of clinical indicators (blood pressure, glucose, lipids, BMI) will be conducted at 12 months. Implementation outcomes (feasibility, acceptability, fidelity) will also be assessed. DISCUSSION: This pragmatic trial integrates a personalized Heart Age risk communication model into routine chronic disease management. By embedding brief, physician-delivered risk feedback within existing primary care workflows, the intervention seeks to improve patient awareness and encourage self-management behaviors without increasing resource burden. Findings will inform the feasibility and scalability of personalized risk communication strategies in low-resource primary care settings. TRIAL REGISTRATION NUMBERS: NCT07045363.
School-partnered collaborative care intervention for young children with type 1 diabetes: A pilot and feasibility protocol.
March CA, Rothenberger S, Naame E … +5 more , Stouffer V, Moon C, Lyon AR, Libman I, Miller E
Contemp Clin Trials · 2026 Apr · PMID 41707755 · Full text
BACKGROUND: Despite advances in treatments, children with type 1 diabetes struggle to achieve glycemic targets. Though school-based programs may help support families to achieve targets, challenges remain with coordinati...
BACKGROUND: Despite advances in treatments, children with type 1 diabetes struggle to achieve glycemic targets. Though school-based programs may help support families to achieve targets, challenges remain with coordinating care between health systems and schools, where students spend much of their day. Monthly, virtual meetings between a parent, school nurse, and a diabetes specialist may bridge this gap by using a shared treatment plan to meet goals. METHODS: This is a pilot cluster-randomized trial to test a school-partnered collaborative care model (SPACE for T1D) for children aged 5-12 years with type 1 diabetes for ≥6 months. School districts were randomized in a 2:1 allocation ratio to the intervention (SPACE for T1D) or enhanced usual care. Participants complete the study over four consecutive months. Parents and school nurses evaluate the feasibility, acceptability, appropriateness, and usability of SPACE using valid questionnaires. The study team monitors retention, fidelity, and practicality. Exploratory outcomes assess change in glycemia, care utilization, type 1 diabetes-related quality of life, self-efficacy skills, and missed class time due to diabetes interventions. RESULTS: Twelve school districts were randomized. One dropped out due to no eligible students, leaving 11 participating districts. We approached 46 students; 30 provided consent for a recruitment rate of 65%. CONCLUSIONS: This study will evaluate the feasibility and acceptability of the SPACE for T1D intervention in varied school districts. Findings will facilitate a fully-powered trial to evaluate the impact on health and academic outcomes, adding to the evidence base of school-based interventions to support youth with chronic disease. NCT: NCT06420661.
Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening (MATCHES): Study protocol for a hybrid 1 stepped-wedge multibehavioral randomized trial.
Abdulla R, Boxtha C, Courtney EP … +17 more , Anyanwu OA, Sutton SK, Chung-Bridges K, Kassaye HG, Philippe E, Mudon KA, Frias E, Parras D, Avrilien N, Friedman M, Turner K, Coronado GD, Champion VL, Tobin JN, Vadaparampil ST, Gwede CK, Christy SM
Contemp Clin Trials · 2026 Apr · PMID 41692274 · Full text
BACKGROUND: The current paper describes the protocol for the Hybrid type 1 effectiveness-implementation trial titled Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening (MATCHES). The aims...
BACKGROUND: The current paper describes the protocol for the Hybrid type 1 effectiveness-implementation trial titled Multilevel Action Toward Colorectal Cancer and Hepatitis C Education and Screening (MATCHES). The aims of the MATCHES intervention trial are to promote both colorectal cancer (CRC) and hepatitis C virus (HCV) screening among patients aged 45-75 years old receiving primary care at a federally qualified health center (FQHC) who are not currently up-to-date with both screenings and to examine implementation outcomes. METHODS: Ten health center sites in the FQHC will be randomized in two waves using a stepped wedge design. Intervention strategies target the system, clinician, and patient levels. System-level strategies include a customized electronic health record best practice alert that pairs CRC and HCV screening and standard operating procedures. Clinician-level strategies include a training session and feedback on screening rates. Patient-level strategies include a theory-informed educational booklet about CRC and HCV screening in English or Spanish and access to stool DNA testing and HCV screening among 350 participants. The primary outcome is both CRC and HCV screening uptake at 12 months post-intervention among 350 participants. System-wide CRC and HCV screening rates among patients 45-75 years old also will be monitored. Implementation barriers and facilitators will be examined. RESULTS: The project is ongoing; effectiveness and implementation outcomes will be determined following study completion. CONCLUSIONS: Results may inform potential subsequent scale-up and offer insights for promoting multiple screening behaviors in a single intervention. CLINICAL TRIALS IDENTIFIER: NCT06745895 (date registered: 2024-12-20); https://clinicaltrials.gov/study/NCT06745895?cond=CRC%20AND%20HCV&rank=.
Screen-and-treat in trauma for opioid misuse prevention using an adaptive intervention (STOMP-AI): Protocol for a pilot sequential, multiple assignment, randomized trial.
Horton DM, Leinweber DL, Salihu E … +10 more , Sarwar T, Muller H, Trevino C, Zaborek J, Chen G, Quanbeck A, Somers T, Almirall D, Zarzaur B, Brown RT
Contemp Clin Trials · 2026 Apr · PMID 41688015 · Publisher ↗
BACKGROUND: Approximately 75% of individuals hospitalized for traumatic injury receive prescription opioids and experience poorly controlled pain, psychological distress, and polysubstance use, placing these individuals...
BACKGROUND: Approximately 75% of individuals hospitalized for traumatic injury receive prescription opioids and experience poorly controlled pain, psychological distress, and polysubstance use, placing these individuals at elevated risk for opioid misuse. Risk factors for opioid misuse vary considerably, following traumatic injury, suggesting similarly variable responses to risk-mitigation attempts. Such heterogeneity necessitates the development of an adaptive intervention, yet no previous trials have evaluated the feasibility of researching nor delivering adaptive interventions to mitigate pain and misuse-related risk, in this population. METHODS: A pilot sequential, multiple-assignment randomized trial (SMART) will be conducted to determine the feasibility of delivering an adaptive intervention initiated within one week of hospital discharge, comprising opioid risk monitoring, trauma care coordination, and pain coping skills training for patients hospitalized for traumatic injury. 107 patients across two Level I trauma centers will be included in the study. Feasibility of conducting the proposed SMART will also be evaluated, including processes for recruitment, retention, randomization and re-randomization, data collection, and qualitative methods. Self-report research surveys, clinical and research visit tracking, fidelity, and qualitative data will be collected at multiple timepoints throughout the trial to inform feasibility and acceptability of the adaptive intervention's components. ANTICIPATED RESULTS: Pilot data will be used to ensure the feasibility and acceptability of the adaptive intervention components, as well as the SMART design. DISCUSSION: Pilot data will be used to develop and refine a manualized adaptive intervention, as well as a fully developed SMART protocol, for optimization-effectiveness testing in a future, full-scale trial. TRIAL REGISTRATION: Registered with clinicaltrials.gov (NCT06527599).
Trial design: Evaluating the safety, feasibility, and acceptability of time-restricted eating in pregnant women with obesity.
DiPiazza B, Patel B, Li Y … +9 more , Tardif A, Pezley L, Fought-Boudaia A, Steffen A, Buhimschi I, Burton T, Varady K, Koenig MD, Tussing-Humphreys L
Contemp Clin Trials · 2026 Apr · PMID 41679537 · Publisher ↗
BACKGROUND: In the United States (U.S.), approximately 15% of women of reproductive age have a body mass index (BMI) of at least 35.0 kg/m, which is associated with increased risks of adverse maternal and fetal health ou...
BACKGROUND: In the United States (U.S.), approximately 15% of women of reproductive age have a body mass index (BMI) of at least 35.0 kg/m, which is associated with increased risks of adverse maternal and fetal health outcomes. However, interventions targeting gestational weight gain have not improved perinatal health outcomes among this population, suggesting the need for innovation. Time-restricted eating (TRE) is an accessible eating pattern in which individuals consume food within a limited time frame each day. We hypothesize that TRE has the potential to optimize gestational weight gain and improve maternal cardiometabolic health and perinatal health outcomes among women with prenatal obesity. METHODS: We describe a randomized controlled pilot study of TRE among pregnant women with a pre-pregnancy BMI between 35 and 60 kg/m. The study aims to enroll 60 participants. The study commences at 14 to ≤20 weeks gestational age and continues through labor and delivery. The TRE intervention includes an 8-h eating window (10 a.m. - 6 p.m. or 11 a.m. - 7 p.m.) during the 2nd trimester and a 10-h eating window (9 a.m. - 7 p.m. or 10 a.m. - 8 p.m.) during the 3rd trimester, for each day of the participants' enrollment in the study. RESULTS: The study will: 1) examine the safety, feasibility, and acceptability of TRE during pregnancy, 2) explore the impact of TRE on maternal body weight and cardiometabolic markers, and 3) explore the impact of TRE on perinatal health outcomes. CONCLUSION: The primary outcomes of this study are focused on examining the safety, feasibility, and acceptability of TRE in pregnant women with class II and III obesity.
Reaching rural veterans: Applying mind-body skills for pain using a whole health telehealth intervention: The RAMP pilot study.
Hadlandsmyth K, Evans R, Leininger BD … +9 more , Taylor BC, Cross LJS, Bangerter A, Hagel Campbell EM, Haley AC, Mahaffey M, Matthias MS, Taylor SL, Burgess DJ
Contemp Clin Trials · 2026 Mar · PMID 41667052 · Full text
PURPOSE: The current study piloted a telehealth, multicomponent intervention for rural Veterans, to increase access to non-pharmacological approaches to managing chronic pain. METHODS: This single arm pilot study examine...
PURPOSE: The current study piloted a telehealth, multicomponent intervention for rural Veterans, to increase access to non-pharmacological approaches to managing chronic pain. METHODS: This single arm pilot study examined the feasibility of trialing the Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention (RAMP). RAMP consisted of an individual session followed by 11 facilitated group sessions (90-min each), that included expert-led educational and experiential physical exercise and mind-body skill-building videos. Feasibility was assessed using pre-specified milestones. for recruitment and enrollment (N = 40), satisfaction (75%), fidelity (90%), intervention engagement (75%), and data collection (surveys of pain and health outcomes at 14 weeks, 80%). FINDINGS: The following milestones were met: 1) 40 rural VA patients with moderate to severe chronic pain were enrolled, 2) 90% of participants were satisfied with the intervention, and 3) facilitators delivered 100% of session activities 100% of the time. The following milestones were nearly met: 4) intervention engagement: 68% of Veterans engaged in at least 7 of 12 sessions, and 5) data collection: 75% survey completion at 14 weeks. Participants reported that the intervention supported their pain self-management capabilities, provided useful self-management opportunities and resources, and enhanced their motivation to self-manage their pain. Participant and other key stakeholders identified important areas for improvement. CONCLUSIONS: Pilot results demonstrated that RAMP is feasible and acceptable to rural Veterans with chronic pain and helped identify optimization strategies to enhance future program engagement.
Early intervention versus treatment as usual for adolescents with first-episode psychosis: Protocol for the randomized OPUS YOUNG trial.
Madsen MS, Melau M, Andersen NK … +18 more , Nielsen CF, Larsen N, Andersen TL, Nordentoft M, Jepsen JRM, Thorup AAE, Jeppesen P, Fagerlund B, Rimvall MK, McGorry P, Singh S, Vernal DL, Hastrup LH, Olsen LR, Rydkjær J, Correll CU, Christensen R, Pagsberg AK
Contemp Clin Trials · 2026 Mar · PMID 41654084 · Publisher ↗
BACKGROUND: The prognosis for early onset psychosis (EOP) is poor for a broad range of outcomes. Early intervention services (EIS) have proven beneficial for adult-onset first-episode psychosis, but no randomized trials...
BACKGROUND: The prognosis for early onset psychosis (EOP) is poor for a broad range of outcomes. Early intervention services (EIS) have proven beneficial for adult-onset first-episode psychosis, but no randomized trials have investigated EIS in samples of patients aged <18 years. We will examine benefits and harms of a new integrated intervention OPUS YOUNG for EOP. The primary objective is to compare the effect of the OPUS YOUNG intervention versus treatment as usual (TAU) on change in social functioning at end-of-treatment after two years. METHODS: This investigator-initiated, single-center, pragmatic randomized clinical trial with blinded outcome assessment takes place in child- and adolescent mental health services in Copenhagen, Denmark. We randomize 290 participants aged 12 to 17 years with first-onset psychosis in a 1:1 ratio to a two-year intervention with OPUS YOUNG versus TAU. The OPUS YOUNG manual builds on the Danish evidence-based intervention for young adults (OPUS) adjusted to meet the specific needs of youths. The primary outcome is social functioning (Personal and Social Performance Scale [PSP] total score). Key secondary outcomes include measures of psychotic, negative, and disorganized symptom dimensions, client satisfaction, and health-related quality of life. Analyses will follow the intention-to-treat principle and use mixed-effects repeated measures models. DISCUSSION: In a rigorous research design, we address the urgent need for evidence-based interventions integrating psychosocial and pharmacological treatments in an age-appropriate manualized program for EOP. The primary trial limitations are the risk of attrition during follow-up, and the inherent inability to mask for allocation in trials with psychosocial interventions. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04916626, registered June 2021. Protocol and modifications is presented here: https://classic. CLINICALTRIALS: gov/ct2/show/NCT04916626.
TELE-SLEEP OSA: A protocol for a hybrid type I randomized clinical trial of telemedicine for obstructive sleep apnea among military dependents and retirees.
Wickwire EM, Capaldi VF, So JY … +8 more , Kim E, Thomas C, Johnston CW, Maggio S, Elmore JS, Albrecht JS, Verceles AC, Chen S
Contemp Clin Trials · 2026 Mar · PMID 41651286 · Publisher ↗
BACKGROUND: Obstructive sleep apnea (OSA) is common and costly in the U.S. military health system (MHS). OSA is associated with poor health outcomes as well as increased economic burden borne by the Defense Health Agency...
BACKGROUND: Obstructive sleep apnea (OSA) is common and costly in the U.S. military health system (MHS). OSA is associated with poor health outcomes as well as increased economic burden borne by the Defense Health Agency. The MHS lacks the capacity to meet the available demand for sleep specialty care. Thus, most military OSA care is provided by private sector TRICARE-contracted civilian providers. Given the burden of OSA and limited access to OSA care, optimizing OSA care within the MHS is vital. TELE-SLEEP OSA is a randomized, parallel group, single blind, controlled clinical trial comparing OSA telehealth care to standard private sector TRICARE. METHODS: Participants will include 160 active-duty family members and Defense Enrollment Eligibility Reporting System beneficiaries who are referred for OSA consultation. Following informed consent, participants will complete baseline assessments prior to randomization. Participants randomized to private sector TRICARE will receive treatment as usual, including positive airway pressure (PAP) therapy. Participants randomized to OSA telehealth care will undergo telehealth consultation with a board-certified sleep medicine specialist, undergo home sleep apnea testing, receive auto-titrating PAP therapy, and receive ongoing support from educator-level sleep navigators throughout the study. Quantitative follow-up assessments will be completed at 30 and 90 days after treatment initiation. Qualitative focus groups to assess participant satisfaction and other implementation outcomes will be conducted with participants from both treatment groups. Outcomes include PAP adherence (primary outcome), OSA symptoms, implementation, and cost-effectiveness. CONCLUSION: Our telemedicine approach to OSA treatment aims to reduce costs and improve health outcomes within the MHS. CLINICAL TRIAL REGISTRATION: NCT07121452.
Impact of clinical trial virtualization on recruitment in underserved communities for a type 2 diabetes mHealth intervention.
Campbell E, Cassells A, Lin TJ … +7 more , Lainez JC, Smaldone A, Desai P, Jia H, Hripcsak G, Tobin J, Mamykina L
Contemp Clin Trials · 2026 Mar · PMID 41643935 · Full text
OBJECTIVE: Approaches to randomized clinical trial (RCT) implementation changed during the COVID-19 pandemic as clinical trials transitioned to largely virtual implementation which may continue in the future. Without car...
OBJECTIVE: Approaches to randomized clinical trial (RCT) implementation changed during the COVID-19 pandemic as clinical trials transitioned to largely virtual implementation which may continue in the future. Without careful consideration, virtual RCTs may exacerbate the historical under-representation of women, the elderly, and racial and ethnic minorities that has occurred in the past. The following study presents an approach to virtualizing an RCT for an mHealth intervention. MATERIALS AND METHODS: Study participants were recruited from Federally Qualified Health Centers in medically underserved areas of the New York City metropolitan area. Recruitment began in January 2020 but was paused in March 2020 due to the COVID-19 pandemic's onset. The research team developed a virtual protocol for recruitment, onboarding, and study implementation. RESULTS: Study participants were predominantly from immigrant, low-income, and racial and ethnic minority groups. Our virtualization approach included an easier-to-understand consent form, expanded virtual training materials, and greater one-on-one attention during training. Despite the transition to virtual protocols, we did not detect statistically significant differences in key demographic characteristics, clinical factors, or mobile device proficiency between recruitment modalities, though the small in-person sample size (n = 21) limits definitive conclusions about selection bias. DISCUSSION: Our study represents an early investigation into how the change from in-person clinical trial recruitment and study implementation to virtual during the COVID-19 pandemic may impact recruitment of participants from medically underserved communities into RCTs. CONCLUSION: This approach may be used in future trials testing mHealth and other technological interventions without exacerbating the under-representation of medically underserved populations.
A randomized controlled trial of cryoprobe versus forceps for transbronchial biopsy (FROSTBITE-2): Study protocol for a multi-center pragmatic clinical trial.
Thiboutot J, Latifi A, Illei P … +16 more , Kapp CM, Maldonado F, Sethi S, Shofer S, Gilbert C, Wahidi M, DeMaio A, Sachdeva A, DiBardino D, Vachani A, Pastis N, Molena D, Jones MR, Rahman NM, Silvestri G, Yarmus L
Contemp Clin Trials · 2026 Mar · PMID 41643934 · Publisher ↗
BACKGROUND: Transbronchial biopsy is a common bronchoscopic procedure that is traditionally performed with forceps. However, its diagnostic capability is limited by small specimen size and crush artifact. A 1.1 mm cryopr...
BACKGROUND: Transbronchial biopsy is a common bronchoscopic procedure that is traditionally performed with forceps. However, its diagnostic capability is limited by small specimen size and crush artifact. A 1.1 mm cryoprobe was developed to overcome these limitations utilizing rapid, controlled, freezing to retrieve larger specimens which are extractable through the bronchoscope's working channel. Whether this improves diagnostic yield remains uncertain. The 1.1 mm cryoprobe has not been directly compared to standard capacity forceps in a prospective, randomized fashion. METHODS: This multicenter randomized controlled trial evaluates whether transbronchial biopsy with a 1.1 mm cryoprobe yields superior diagnostic yield compared to standard capacity forceps in adults undergoing transbronchial biopsy for diffuse parenchymal lung disease, parenchymal pulmonary lesions, or lung allografts. Participants will be randomized 1:1 to either biopsy tool, stratified by indication. Primary outcomes include indication-specific and overall diagnostic yield, adjudicated by centralized pathology review. Secondary outcomes include histologic quality metrics and complication rates. This trial is individually powered for each indication-specific primary outcome, and can detect an 11.3% difference in overall diagnostic yield with 250 participants per arm. DISCUSSION: This trial will provide high-quality evidence to guide transbronchial biopsy tool selection to maximize diagnostic yield. Results of this trial may yield practice changing data for the evaluation of patients with diffuse parenchymal lung disease, parenchymal pulmonary lesions, and lung allografts. Unique design features include the use of a centralized histopathology core to minimize bias and interobserver variability and a pragmatic design to facilitate integration into clinical workflows and optimize recruitment.
The Clinical Trial Referral Ambassadors program to promote clinical trial referrals within rural community hospitals: A formative program evaluation study.
Carey D, Tolle C, Kim J … +4 more , Mullett T, Occa A, Ray AE, Stapleton JL
Contemp Clin Trials · 2026 Mar · PMID 41621470 · Full text
BACKGROUND: Community hospitals often lack research infrastructure, leading to fewer research opportunities for patients and low trial accrual rates. In practice, community hospitals can develop partnerships with academi...
BACKGROUND: Community hospitals often lack research infrastructure, leading to fewer research opportunities for patients and low trial accrual rates. In practice, community hospitals can develop partnerships with academic facilities to refer patients for research opportunities but there is a dearth of research related to facilitating such referrals. We developed and implemented the Clinical Trial Referral Ambassadors (CTRA) training program to support trial referral efforts by nurses and clinic staff at community hospitals. This report describes CTRA and results from a formative evaluation. METHODS: CTRA was designed to create clinical research referral "Ambassadors" among nurses and research staff at community hospitals who can speak confidently to physicians and patients about the referral process and assist in facilitating referral activities. CTRA is grounded in best practices for community oncology training programs and includes didactic and interactive sessions, communication skills building, and self-assessment/discussions. The program evaluation included a post-training survey to assess acceptability and preliminary outcomes. RESULTS: Of the 25 individuals enrolled in CTRA, 13 (52%) attended all training sessions and 9 (36%) engaged in at least one session. Training acceptability ratings (evaluation survey n = 16) were favorable and participants reported high levels of confidence in their ability to refer patients, understanding of trials, and motivation to increase referrals after CTRA. CONCLUSION: Preliminary evidence suggests the CTRA is acceptable and increased participants' knowledge, motivation, and skills for referring patients to clinical research. Future directions include identifying strategies to bolster CTRA participation and testing the impact of CTRA on trial referral rates.
Protocol for a single-arm, multi-component behavior change technique (BCT) intervention to develop a walking habit among caregivers for persons with Alzheimer disease and related dementias (ADRD).
Miller D, Jordan L, Lambert S … +6 more , Goodwin AM, Sinvani L, Perrin A, Cheung YK, Davidson KW, Butler MJ
Contemp Clin Trials · 2026 Mar · PMID 41621469 · Full text
Even low to moderate physical activity is critical in improving and maintaining physical health and well-being. Caregivers of people living with Alzheimer disease and related dementias (ADRD) are a burdened population an...
Even low to moderate physical activity is critical in improving and maintaining physical health and well-being. Caregivers of people living with Alzheimer disease and related dementias (ADRD) are a burdened population and, as such, can experience challenges with managing even modest increases in physical activity while caring for others. While some interventions have been proposed to increase physical activity, many fail to consider the unique needs of caregivers of people with ADRD. The purpose of this 12-week decentralized behavioral trial is to test the efficacy of a multi-component, personalized text-message delivered BCT intervention to encourage the formation of a daily walking habit among caregivers of persons with ADRD assessed by Fitbit activity trackers via the key mechanism of behavior change (MoBC) of behavioral automaticity. Formation of a daily walking habit will be defined as attainment of walking 1000 or more additional steps during the same one-hour period on 7 consecutive days as set up in a personalized walking plan. We will also evaluate the association of habit formation attainment with changes in behavioral automaticity, association between longitudinal behavioral automaticity and habit formation attainment over time, and the heterogeneity of treatment effects between participants. Results will advance science about behavioral habit formation among caregivers for persons with ADRD and determine whether behavioral automaticity acts as the primary MoBC for the effect on this BCT intervention on daily habitual walking. This trial is registered on www.ClinicalTrials.gov (https://clinicaltrials.gov/study/NCT06803797); NCT #: NCT06803797.
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